Job Title

Principal Biostatistician Early Phase (PK) CAD $240,000 base Fully remote - Canada Influence early-phase clinical strategy and PK-driven decision making across an innovative development portfolio About Join a leading global provider within the biotech/pharma space, supporting an innovative clinical development portfolio focused on advancing therapies that address significant unmet medical needs. This role sits within early clinical development, with a strong emphasis on healthy volunteer studies and PK/PD endpoints. The environment is scientifically rigorous, collaborative, and fast-paced, with meaningful upcoming development milestones. Why This Role Matters Early-phase studies set the trajectory for an entire program. In this role, you will provide senior-level statistical expertise to ensure robust design, high-quality analysis, and clear interpretation of PK data that directly informs downstream clinical and regulatory strategy. The team is seeking someone with genuine hands-on PK experience who enjoys owning their work while collaborating closely with Clinical Pharmacology, Clinical Development, and Data Management. What You Will Do Provide statistical leadership for early-phase clinical studies with PK/PD endpoints Author statistical sections of protocols, including sample size calculations Develop and review SAPs, randomization specifications, datasets, and TLFs Perform and validate analyses using SAS (R a plus) Contribute to clinical study reports and regulatory documentation Partner cross-functionally to ensure aligned timelines and high-quality deliverables Support exploratory and IND-enabling analyses where required What You Bring PhD in Statistics/Biostatistics with 3+ years of industry experience, or MS with 5+ years 2+ years of hands-on experience analyzing non-compartmental PK endpoints in industry Strong understanding of ICH GCP and regulatory expectations for clinical pharmacology studies Experience working with CDISC standards (SDTM, ADaM, CDASH) Proficiency in SAS for independent analysis and validation Ability to independently manage projects and make sound statistical decisions Strong communication skills and experience collaborating with cross-functional teams Preferred: Exposure to statistical modeling, simulation methods, or PD/biomarker analyses. Why Its Special Fully remote across Canada High-impact early development work Strong balance of autonomy and collaboration Opportunity suited to someone senior yet still technically hands-on Stable environment with long-term visibility